September 29, 2026
EUDAMED UDI Registration Checklist for Manufacturers
Using the EUDAMED UDI/Devices module became mandatory on 28 May 2026. This follows the Commission Decision (EU) 2025/2371, which formally
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September 28, 2026
Meet the Team: Eva Kurilova-Sahin
We are pleased to welcome Eva Kurilova-Sahin to the MedQAIR team. Eva brings a background in medicine, clinical science, radiology,
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September 25, 2026
EU AI Act Requirements for AI-Enabled Medical Devices
The regulatory landscape for medical devices is becoming more complex as artificial intelligence becomes part of diagnosis, monitoring, treatment, and
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September 4, 2026
Digital Authorised Representative: A Smarter Approach to Medical Device Compliance
For manufacturers based outside the EU, appointing an Authorised Representative for medical devices is an important part of accessing the
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August 21, 2026
SaMD technical documentation checklist for MDR submission
Software as a medical device (SaMD) has to meet the same technical documentation obligations as any other device under
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August 16, 2026
Medical Device Regulatory Strategy: How to Build a Clear Path to Market
A medical device regulatory strategy sets out, before development gets far, which rules apply to a product, which market approvals
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August 14, 2026
ISO 13485 Quality Management System Requirements for Medical Device Companies
A medical device quality system has to do more than document procedures. It needs to give an organisation a controlled
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July 24, 2026
When does healthcare AI fall under the EU AI Act?
An overview of the first episode of NEN’s podcast on AI in healthcare AI keeps turning up across everyday care,
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June 23, 2026
EC REP to EU REP: What the OJEU Publication Means in Practice
On 17 June 2026, the European Commission published the reference of EN ISO 15223-1:2021/A1:2025 in the Official Journal of the
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